Objective: The objective of this study is to determine the safety and tolerability of Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers (HCWs) at Henry Ford Hospital.

Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in combination with Truvada, as assessed by review of completion rates of PEP and also review of completed safety data.

Each health care worker will receive one of the Treatment Arms for 28 days.

Other Names:

Truvada

Isentress

Kaletra

Active Comparator: Raltegravir

Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.

Drug: emtricitabine/tenofovir disoproxil fumarate

Each health care worker will receive one of the Treatment Arms for 28 days.

Other Names:

Truvada

Isentress

Kaletra

Detailed Description:

Health Care Workers that have occupational exposure to blood are at risk for HIV infection. Prevention of blood exposure, through safer practices, barrier precautions, safer needle devices, and other innovations, is the best way to prevent infection with HIV and other bloodborne pathogens.

Though these strategies have been successful in reducing the frequency of blood exposure and needlestick injuries in the past decade, the hazard has not been eliminated. As of December 2001, the CDC had received voluntary reports of 57 documented cases of HIV seroconversion temporally associated with occupational exposure to HIV among U.S. health care personnel. An additional 138 infections among health care personnel were considered possible cases of occupational transmission. Because there is no cure or effective vaccine for HIV, optimal post exposure care, including the administration of antiretroviral drugs to prevent HIV infection, remains a high priority in protecting health care workers.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Adult (at least 18 years of age)employees of HFH

History of occupational exposure to bodily fluids

Negative HIV test

The ability to understand a written informed consent form, which must be obtained prior to initiation of any study procedures

Exclusion Criteria:

Positive pregnancy test

Females who are breastfeeding

History of renal disease

Contraindication for treating patient with components of PEP regimen

Greater than one dose of PEP medication for this exposure event

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234116